FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM
K Number: K130298
·
Decision Jun 18, 2013
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
93
Applicant Total
41
Review Days
131
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Basic Information
- Device Name
- BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM
- K Number
- K130298
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biopro, Inc.
- Date Received
- February 7, 2013
- Decision Date
- June 18, 2013
- Product Code
- JDW
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JDW | Pin, Fixation, Threaded | FDA class 2 | Orthopedic |
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